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Director, Medical Safety

Bengaluru, KA
Job Code:
  • Biotechnology & Science
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Job Details

Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summaryCompose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirementsServe as an internal consultant to pharmacovigilance case processing teams on projects being supportedProvide aggregate reviews of safety information, including clinical data, to maintain oversight of a products safety profileProvide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical dataRepresent safety and clinical data review findings during client meetingsProvide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic ReportsProvide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation StrategiesProvide medical oversight for label development, review and changeProvide medical support and attendance at Data Safety Monitoring Board MeetingsAttends and contributes medical safety evaluation on Safety Monitoring CommitteesProvide medical safety contributions to the Integrated Safety Summary or Common Technical DocumentProvide medical review and edits to Drug Safety Reports or other benefit-risk assessmentsReview and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contractPerform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.Act as Global Safety Physician or Assistant or Back-up on projects as assignedServe as the Global Lead for a medical safety project requiring a team of medical safety advisors; being responsible for project specific training, operational delivery, project communication, and quality controlAttend project meetings, medical safety team meetings, and client meetings as requestedEnsure coverage for all medical safety deliverables within regulatory or contracted timelinesProvide medical escalation support for medical information projectsProvide medical escalation support for EU Qualified Persons for Pharmacovigilance projects24 hour medical support as required on assigned projectsMaintain awareness of medical-safety-regulatory industry developmentsParticipates in the review of Requests for Proposal, vetting, proposing and budgeting of medical safety servicesAttends bid defenses and other client meetings to promote and sell medical safety servicesLine manage a team of regionally or globally based physicians performing the tasks of a global medical safety physician ensuring operational delivery of assigned projects and professional development of direct reportsAccount for financial performance of assigned medical safety projectsEvaluate assigned staff workload and volume projections in order to ensure appropriate balance of project assignments for direct reportsEnsure appropriate resourcing and coverage of assigned global projects, regardless of regional holidaysEnsure that departmental goals, objectives, policies, and procedures are communicated, understood, and implementedSupervise assigned direct reports and provides mentoring as required; identifying ongoing training and development needs of assigned staffRecommend course of action on management/human resources matters, including salary administration, transfers, hiring, terminations, professional development, performance appraisals, and employee counselingParticipate in the Global Medical Safety Management Team to drive service line growth, differentiation, and strategyRepresent global medical safety service line to regional stakeholders, internal and externalAttend key meetings pertinent to service line and maintain connections with key clients of service lineServe as a resource and participate in strategic business development activities including presentations to prospective clients, professional meetings, and other business development activitiesPerform special projects as requested by management All responsibilities are essential job functions unless noted as nonessential (N).REQUIRED KNOWLEDGE, SKILLS AND ABILITIESKnowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practiceKnowledge of clinical trials and pharmaceutical research processAbility to establish and meet priorities, deadlines, and objectives.Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility.Ability to establish and maintain effective working relationships with coworkers, managers and clientsLeadership skills and aptitude for financial and project management QualificationsMINIMUM REQUIRED EDUCATION AND EXPERIENCEA medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education and 5 years experience practicing clinical medicine after award of medical degree; or equivalent combination of education, training and experience; Graduate medical training can qualify for clinical practice experience. Three years of clinical practice experience with two additional years as a pharmaceutical physician in any role can also suffice;Five years of medical safety or medical monitoring experience in the pharamceutical or associated industry; or relevant applicable experienceA valid medical license, or equivalent, from the country or region in which he/she resides and worksPHYSICAL REQUIREMENTSExtensive use of telephone, email, and face-to-face communication requiring accurate perception and elocution of spoken and written EnglishExtensive use of keyboard requiring repetitive motion of fingersRegular sitting for extended periods of timeThe ability to travel based on client or company needs, approximately 10% of time If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team. Connect to great opportunity
Degree: MD/ MS (Medicine) | Ph.D. (Doctorate)

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 5-10


Admin Services/Medical Facilities | Medical Superintendent/Director | Regulatory Affairs
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